FDA UDI
In Commercial Distribution
🇺🇸 United States
VisuCon-F Frozen Coag Screen N
DI: 10629009074811
·
Model: FCSN0481
·
Affinity Biologicals Inc
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
81
Basic Information
- Brand Name
- VisuCon-F Frozen Coag Screen N
- Primary DI
- 10629009074811
- Version / Model
- FCSN0481
- Company Name
- Affinity Biologicals Inc
- Labeler DUNS
- 249373515
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 81
- Record Status
- Published
- Publish Date
- 2017-04-28
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 36e1c870-e5b8-47cc-b563-6d4ca7f20953
Device Description
Intended for use in the quality control of quantitative coagulation assays, including Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) and Fibrinogen, in the normal range.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GGN | Plasma, Coagulation Control | Hematology | 864.5425 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 30590 | Multiple coagulation factor IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of one or multiple coagulation factors, coagulation intermediates and/or their activated components in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10629009074811 | GS1 | ||||
| Unit of Use | 10629009070042 | GS1 | ||||
| Previous | 16290090074819 | GS1 |
Customer Contacts
- Phone
- 1-800-903-6020
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K110432 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at or below -60°C